Swiss Automation Inc.

Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.

Business Wire 09.22.21

Tubing & Extrusion

Accu-Tube Appoints Matthew Haddle as CEO

Haddle has a track record of leading organizations through strategic expansions across the medical device, aerospace, and industrial sectors.

Accu-Tube 09.22.21

First CellFX Procedure Performed in Canada

Pulse Biosciences expands its controlled launch of the CellFX System into the country.

Business Wire 09.22.21

Turner Imaging Systems Announces International Expansion

Company forges marketing agreement in the U.K. and Ireland.

Business Wire 09.22.21

RedDress’ ActiGraft System Receives New FDA Clearance

ActiGraft Ver.02 System is intended for the safe and rapid POC preparation of an in-vitro blood clot.

Globe Newswire 09.22.21

Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

The two deals will strengthen Heraeus' healthcare and medtech portfolio.

Heraeus 09.22.21

MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021

Attendees of The MedTech Conference, powered by AdvaMed, will vote for the Grand Prize winner.

MedTech Innovator 09.21.21

CareDx Appoints Hannah Valantine to its Board

Valantine is a professor of Medicine at Stanford and the former National Institutes of Health chief scientific officer for Scientific Workforce Diversity.

Globe Newswire 09.21.21

Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech

Electroducer Sleeve based on a medical technique called Direct Wire Pacing, which was invented by the company’s founder.

Electroducer 09.21.21

OmniVision Debuts Industry’s First 8 Megapixel Medical-Grade Image Sensors

The OH08A/B image sensors provide high resolution with excellent image quality for 10-12mm outer diameter endoscopes.

OmniVision Technologies Inc. 09.21.21

Diagnostics

FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests

May be related to current mixing parameters of the PCR reaction mixture.

U.S. Food and Drug Administration 09.20.21

Diagnostics

Babson Diagnostics Raises $31 Million in Series B Funding

Money will be used to help drive commercialization of customer-first, highly accessible diagnostic blood testing.

Business Wire 09.20.21

Paragonix Launches Global Registry for Studying Donor Lung Preservation

Registry will capture data on how organ preservation and transportation impact patient outcomes in lung transplantation.

Business Wire 09.20.21

Picarro Unveils EtO Gas Concentration Analyzer

Analyzers are now available for CEMS, stack testing, fenceline, and ambient monitoring systems.

PR Newswire 09.20.21

Diagnostics

FDA Clears Inova Diagnostics' Digital Multi-Analyte System

The product, Aptiva, received CE marking in August 2020.

PR Newswire 09.20.21

Cardiovascular

FDA Approves Abbott's Portico with FlexNav TAVR System

Self-expanding TAVR valve features intra-annular (within the native valve) leaflets.

PR Newswire 09.20.21

PTI Engineered Plastics Wins a 2021 Macomb Business Award

Organization Receives Top Honors in Hometown Hero Category

Patient Monitoring

VitalConnect Launches New Version of VistaCenter for Cardiac & Remote Patient Monitoring

Brings market-leading patient management and monitoring tools to physicians.

VitalConnect Inc. 09.16.21

Medical Devices Market to Top $671.49 Billion by 2027

Wearables and rising cases of chronic diseases will help fuel growth, industry data predicts.

Precedence Research 09.16.21

Improved Outcomes Proven With Insulet’s Omnipod 5 System

Studies show the automated insulin delivery system improved HbA1c nearly one percentage point in kids and 0.60 percent in adolescents and adults.

Business Wire 09.16.21

Diagnostics

Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA

Expands precision medicine and transforms care delivery.

Siemens Healthineers 09.14.21

Patient Monitoring

Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe

Uses 12 LEDs to simultaneously offer 12 blood constituent parameters noninvasively and continuously.

Business Wire 09.13.21

RapidPulse Closes $15 Million Series A Financing

Two industry veterans join the team to support the development of a cyclic aspiration system for ischemic stroke.

Globe Newswire 09.10.21

Quanta Raises $245 Million in Series D Funding Round

Money will help accelerate the commercialization of the company's SC+ Portable Hemodialysis System.

Business Wire 09.10.21

Thermo Fisher Scientific Launches Updated COVID-19 Test

Updated version of highly sensitive and accurate COVID-19 PCR kit accounts for known and future viral mutations.

PR Newswire 09.10.21

Know Labs Awarded New Patent for Non-Invasive Diagnostic Tech Platform

Company has been granted 22 patents to date and has 35 more pending.

Business Wire 09.09.21

Vicarious Surgical Opens New Corporate Headquarters in Massachusetts

The new space houses a full-scale operating room for robotics testing as well as R&D and company operations.

Business Wire 09.09.21

908 Devices Develops New Data Integrations With Key Industry Partners

Integration of Sartorius SIMCA and Securecell Lucullus PIMS with REBEL Spent Media Analyzer allows for data-driven decisions.

Business Wire 09.09.21

Luis J. Malavé Joins Integrity Applications Board

New member has more than 30 years of leadership experience in the medtech industry, primarily in diabetes management.

Globe Newswire 09.08.21

Surgical

Stryker Buys Gauss Surgical

Gains Triton AI-enabled platform for real-time monitoring of blood loss during surgery.

PR Newswire 09.07.21

Neurological | Software & IT

Mayo Clinic, Google Research AI Software Could Boost Brain Stim Devices

Algorithm may help understand which brain regions directly interact with one another.

Mayo Clinic 09.07.21

Roche's COVID-19 Molecular Test Granted EUA

First test authorized for use in screening, testing asymptomatic and symptomatic individuals with results within 20 minutes.

PR Newswire 09.02.21

SCIEX Debuts the ZenoTOF 7600 System

System delivers new capabilities for life science research and biotherapeutic development.

Business Wire 09.02.21

Bright Future Ahead for Renal Denervation

No devices yet approved in the United States for the high blood pressure treatment.

GlobalData 09.02.21

Cardiovascular

Abbott Buys Walk Vascular, a Thrombectomy System Maker

Adds mechanical thrombectomy devices for treating patients with peripheral blood clots.

PR Newswire 09.02.21

Diagnostics

GE Healthcare Reveals AMX Navigate Portable X-Ray System

Helps address technologist stress and strain and improve efficiency.

Business Wire 09.01.21

Sectoral Asset Management Invests $9M in Cagent Vascular

Money will be used to help manufacture and commercialize the Serranator product.

Business Wire 09.01.21

Surgical

Boston Scientific Closes Lumenis Surgical Biz Deal

Company gains laser systems, fibers, and accessories for urology and otolaryngology procedures.

PR Newswire 09.01.21

Electronics | R&D & Design

Closed Loop Thermal Control in Medical Devices

A closed-loop feedback approach is an effective mechanism to address thermal control challenges.

Kenneth MacCallum, P.Eng., Principal Engineering Physicist, StarFish Medical 08.30.21

Molding

Westfall Technik Opens New Medical Molding Plant and Clean Room

The 40,000-square-foot facility near Chicago features three Class 8-certified clean rooms and one white space for helping firms meet GMP requirements.

Business Wire 08.30.21

Ramin Mousavi Appointed CEO of CathWorks

New leader worked at Baxter International and Edwards Lifesciences.

PR Newswire 08.27.21

Diagnostics

Vivante Health Expands Product Suite by Unveiling GIMate

Handheld breath hydrogen monitor measures hydrogen concentration in the breath.

PR Newswire 08.26.21

Digital Health

Why Patient Data Security is of Essential Importance in 2021

How to protect confidential patient information and comply with regulations such as HIPAA.

Anton Zheliabin, Product manager, ComeBack Mobility 08.25.21

Packaging & Sterilization

Amcor Launches Enhanced Heat Seal Coating Technology

New heat seal adhesive helps medical device manufacturers better mitigate risk for greater patient safety.

Amcor 08.23.21

Cardiovascular

Biomedical Engineers Grow 3D Bioprinted Blood Vessel

Paves the way for possible cardiovascular drug advancements with better precision.

Texas A&M Engineering 08.19.21

Digital Health

iCAD Signs Global Distribution Agreement With Sectra

Agreement will expand access to ProFound AI and ProFound AI Risk to more facilities and imaging centers worldwide.

Globe Newswire 08.19.21

Butterfly Network Building New Corporate Headquarters in Massachusetts

New facility will have the capacity for approximately 275 people with the ability to expand further.

Business Wire 08.19.21

Cardiovascular

Abiomed's Impella ECP Heart Pump Granted Breakthrough Status

The world’s smallest heart pump, according to the company.

Business Wire 08.19.21

Diagnostics

EchoNous’ Lexsa Linear Probe Cleared by FDA

An ultra-portable device capable of producing diagnostic-quality images rivaling those from larger, more expensive cart-based units.

EchoNous 08.19.21

Diagnostics

Illumina Closes $7.1B GRAIL Deal Despite Antitrust Challenges

GRAIL will remain a separate and independent unit, pending ongoing regulatory and legal review.

PR Newswire 08.19.21

Electronics

Freudenberg Medical Increases Capabilities for Sensor Integration

Positions the company to work with sensors such as temperature and pressure sensors, entire sensor arrays, and fiber optic sensors.

Freudenberg Medical 08.18.21

Diagnostics

FDA Extends EUA for Spectrum Solutions’ SDNA-1000 Saliva Collection Device

New authorization includes the unsupervised self-collection of saliva for COVID-19 testing.

Spectrum Solutions 08.18.21

Machining & Laser Processing

The Importance of Metal Fabrication in the Innovation of Medical Devices

How metal fabrication powered by CNC machines has come to the rescue of the innovation of medical devices.

Peter Jacobs, senior director of marketing at CNC Masters 08.17.21

R&D & Design

Trelleborg Launches Rapid Development Center in Minnesota

Provides Trelleborg’s healthcare and medical customers a single partner for design, rapid prototyping, development and serial production.

Trelleborg 08.16.21

Health Canada Approves Butterfly iQ+ Platform

The second-generation handheld device is now available in 20 countries worldwide.

Business Wire 08.13.21

Satellite Healthcare, Outset Medical Partner to Boost Home Dialysis

Outset Medical’s Tablo Hemodialysis System selected as the tech to further enable Satellite Healthcare’s efforts to drive home hemodialysis growth.

Business Wire 08.13.21

HD Medical Appoints Shaun Setty as Chief Medical Officer

Cardiothoracic surgeon positions the company for growth in the CVD detection and monitoring market.

Business Wire 08.13.21

First Clinical Use of SoundBite Medical's Active Wire Platform

Doctors tout strong results with the company's Active Wire 0.014-inch platform in severely calcified peripheral lesions.

Business Wire 08.13.21

Diagnostics

Siemens Healthineers Develops COVID-19 Severity Algorithm

Helps predict the potential likelihood of progression to severe disease and life-threatening multiorgan dysfunction in COVID-19 patients.

Siemens Healthineers 08.12.21

BD Names Christopher DelOrefice as EVP and CFO

DelOrefice joins the company from Johnson & Johnson.

BD 08.12.21

Digital Health

Four Real-World Applications for Voice Tech in Healthcare

How voice enablement is impacting seniors and healthcare professionals.

Bruce Ryan, Director of Engineering, Harman Embedded Audio 08.11.21

Cardiovascular

Philip Morris International Acquires OtiTopic

PMI will use the purchase to grow its pipeline of ‘Beyond Nicotine’ inhaled therapeutic products.

Philip Morris International Inc. 08.11.21

Surgical

FDA OKs Boston Scientific's EXALT Model B Single-Use Bronchoscope

Designed for bedside procedures in the ICU and OR.

PR Newswire 08.10.21

Nolato AB Finalizes Two North American Expansions

Adds space for new programs in Vermont and Wisconsin.

Nolato AB 08.10.21

Neurological | Software & IT

FDA OKs SpinTech's STAGE MRI Software

Allows scanning the entire brain in roughly five minutes.

PR Newswire 08.09.21

Diagnostics | Digital Health | Software & IT

GE Healthcare, AWS Partner to Transform Care Delivery

AI-based imaging applications and Edison Health Services platform on AWS.

Business Wire 08.09.21

Patient Monitoring

LifeSignals Inc. Receives FDA Approval for Remote Monitoring Platform

The LX1550 Platform can be used by clinicians for the continuous collection of patient physiological data at home and in healthcare settings.

LifeSignals Inc. 08.05.21

Cardiovascular

Early Catheter Ablation of VT Outperforms Conventional Medical Therapy

First randomized trial of its kind to enroll patients with nonischemic cardiomyopathy.

Heart Rhythm Society 08.05.21

ASTM International, NSERC HI-AM Network Sign MOU

The agreement will support the development of additive manufacturing standards.

ASTM International 08.05.21

Draper Makes Advances in Extracorporeal Membrane Oxygenation

Develops artificial lung technology with $4.9 million army grant.

08.04.21

Digital Health

How Medical Device Connectivity Is Improving Accessibility in Healthcare

The fifth generation of wireless connectivity sets the stage for better medical devices.

Adrian Johansen 08.03.21

Digital Health

Baxter Begins Collaboration with Amazon Web Services

Advancing strategic priorities in digital health, customer experience, and technology modernization.

Baxter 08.03.21

Materials

Smaller Devices Require More Efficient Material Integration

Silicones are becoming increasingly well-suited for implantable medical devices and combination products.

Michael Barbella, Managing Editor 08.03.21

Chronic Disease | Patient Monitoring | Software & IT

FDA OKs Abbott's FreeStyle Libre 2 iOS App

Users can check glucose with a compatible iPhone every minute with optional real-time glucose alarms.

Abbott Laboratories 08.02.21

Digital Health

Hello Heart Raises $45M to Expand Digital Heart Health Platform

Series C financing was led by IVP and includes existing investors.

Business Wire 08.02.21

Materials

Pandemic Underscores Importance of Medtech Material Innovation

Materials must meet the changing needs of medtech and society in general through preventative, diagnostic and therapeutic solutions.

Michael Barbella, Managing Editor 07.30.21

Foxx Life Sciences Expands with Two New Manufacturing Facilities

The new locations add four additional Single Use Technology Cleanrooms.

Foxx Life Sciences 07.30.21

Cardiovascular | Digital Health

BioFourmis' Digital Heart Failure Therapeutic Earns Breakthrough Status

Augments guideline-directed use of heart failure medications.

PR Newswire 07.30.21

Cardiovascular

Successful First Human Use of Foldex's Biopolymer Mitral Heart Valve

Second product from Tria Biopolymer Valve portfolio to move into human study.

Business Wire 07.30.21

Diagnostics

KA Imaging Forges U.S. Distribution Deal With Alpha Imaging

Alpha Imaging serves 14 states in the Northeast, mid-Atlantic, and central U.S.

KA Imaging 07.30.21

Neurological

Nevro Corp Receives FDA Approval for Senza System

The 10 kHz high frequency spinal cord stimulation therapy is designed for treatment of chronic pain associated with painful diabetic neuropathy.

Nevro Corp. 07.29.21

Outset Medical Appoints Katie Szyman to its Board

Szyman joins four other female leaders on the company's Board of Directors.

Outset Medical Inc. 07.29.21

Confluent Medical Expanding Costa Rica Manufacturing Facility

Company is adding capacity for nitinol processing and catheter manufacturing.

Business Wire 07.29.21

3D/Additive Manufacturing | Software & IT

3D Systems Sells Simbionix to Surgical Sciences for $305M

Divestiture results from company’s singular focus on additive manufacturing.

3D Systems 07.29.21

Gerald R. Mattys Joins Pelvital USA Board of Directors

Newest member most recently served as CEO at Tactile Medical.

Business Wire 07.29.21

Chronic Disease

Rice Team Building Insulin-Producing Implant for Type 1 Diabetes

JDRF funds creation of implant to automatically regulate blood glucose levels.

Jade Boyd, Rice University 07.27.21

'Yo-Yo' Growth Seen for Global Respiratory Protective Equipment Market

High costs associated with supplied-air respirators could act as a bottleneck to the market expansion, however.

Globe Newswire 07.27.21

Patient Monitoring

FDA OKs LifeSignals' LX1550 Multiparameter Remote Monitoring Platform

Delivers continuous remote patient vital signs monitoring in both hospital and home.

PR Newswire 07.27.21

Global Peripheral Intravenous Catheter Market to Reach $7.3B by 2027

Driving the sector are trends such as the increasing incidence of chronic and life threatening diseases.

Business Wire 07.27.21

Materials

Disinfectant Resistance is Crucial in Medtech Material Selection

Understanding the kinds of materials that stand up to healthcare-grade disinfectants can help ensure device longevity.

Michael Barbella, Managing Editor 07.27.21

Cardiovascular

Data Confirm the Accuracy of HeartFlow Planner in Modeling Post-PCI Outcomes

The interactive planning tool enables heart teams to modify vessels virtually and determine the optimal treatment strategy before procedures.

Business Wire 07.23.21

Materials

Electronics Integration Impacting Medtech Materials

Conductive materials are becoming a necessary part of medical devices as digital healthcare continues to evolve.

Michael Barbella, Managing Editor 07.23.21

BD Acquires Velano Vascular

Will use innovative needle-free blood draw technology to reduce pain and discomfort of multiple needlesticks.

BD 07.22.21

ONI Welcomes Dr. Tyler Ralston as Chief Technology Officer

Visionary technology creator will help drive future innovations in single cell microscopy applications.

Business Wire 07.20.21

Chronic Disease

Integra Highlights Data from Diabetic Foot Ulcer Study

Positive clinical outcomes for PriMatrix dermal repair scaffold for management of hard to heal diabetic foot ulcers.

GlobeNewswire 07.20.21

Cardiovascular

CARMAT Celebrates First Aeson Artificial Heart Commercial Implant

Represents first CARMAT sale, paves the way for the company’s commercial development.

Business Wire 07.20.21

Diagnostics

Owlstone Medical Launches Breath Testing for Digestive Health

Testing enables patients to take better control over their digestive health through a simple at-home breath test.

Owlstone Medical 07.19.21

Global Enteral Feeding Devices Market to Reach $4.85 Billion by 2027

Innovation and product launches are expected to drive growth.

Business Wire 07.14.21

Digital Health

DataRobot Launches AI for Health Incubator

Company is accelerating critical healthcare research to help physicians and medical professionals better leverage AI.

Business Wire 07.14.21

Second Sight Touts Cortical Prosthesis Study Results

Preliminary findings show participants benefit from Orion Visual Cortical Prosthesis.

Business Wire 07.14.21

Diagnostics

Hologic Gains CE Mark for Saliva Samples with COVID-19 Test

Hologic has shipped over 100 million Aptima COVID-19 tests globally since spring 2020.

Business Wire 07.14.21

Cardiovascular

HeartFlow Completes Patient Enrollment in the PRECISE Trial

More than 2,000 patients enrolled in randomized controlled trial to evaluate a precision-testing pathway for suspected coronary artery disease.

Business Wire 07.13.21

Fluid Management System Market to be Worth $23.2 Billion By 2028

North America dominated the global market for fluid management system in 2020 and will continue that dominance over the next seven years.

Polaris Market Research 07.13.21

Avanos Medical Fined $22M for MicroCool Surgical Gown Misbranding

Gowns were falsely labeled as providing the highest level of protection against fluid and virus penetration.

U.S. Department of Justice 07.12.21

Xenter Appoints Four Healthcare Industry Leaders to its Board

Company also closes a $12 million Series A stock offering.

Business Wire 07.12.21

3D/Additive Manufacturing

Desktop Health Adds PhonoGraft Platform to Its Technology Platform

Will support the body’s functional and morphological regeneration of the tympanic membrane.

Desktop Health 07.09.21

Contraline Expands Board of Directors

Medical device industry veteran Martin J. Emerson has joined the company's board.

Business Wire 07.09.21

Digital Health

ClearDATA, BioIntelliSense Collaborate to Enhance RPM Security and Compliance

Compliant transmission of medical grade data from the home enables providers to safely monitor patients and meet demand for scalable remote care.

Business Wire 07.09.21

Neurological

Royal Philips Enters Strategic Partnership with NICO.LAB

Advances its commitment to improving outcomes for people who suffer a stroke.

Philips 07.08.21

Cardiovascular

Enrollment Underway in Philips' WE-TRUST Stroke Study

Will assess impact of the Direct to Angio Suite workflow in improving patient outcomes.

Philips 07.07.21

Confluent Medical Invests in The Electrospinning Company

The investment will enable Confluent to expand its design options used in structural heart markets.

Business Wire 07.07.21

EU MDR Preparedness: How Is COVID-19 a Factor?

Properly plan ahead so that your company can tackle regulatory hurdles without any struggles.

Jon Speer, Founder of Greenlight Guru 07.06.21

Contract Manufacturing

Receiving FDA Approval in Under One Month

How the team working on an “Open-Source” COVID Ambu-bot Ventilator optimized its short timeline.

Aaron Burlew, Senior Applications Engineer, Teknic Inc. 07.06.21

Diagnostics

FDA OKs Siemens Healthineers' MAGNETOM Free.Max MR Scanner

Company’s smallest, most lightweight scanner uses less than 1 liter of helium and no quench pipe.

Business Wire 07.06.21

Contract Manufacturing

MPE Inc. Expands Into EMEA Market

Company has hired a director of International Markets to help lead the expansion.

PR Newswire 07.06.21

Surgical

Robocath Completes First Robotic Coronary Angioplasties in Belgium

The first robotic procedures are part of a clinical study which involves six European centers.

Robocath 07.02.21

Surgical

FDA Clears Standard Bariatrics' Stapling Technology for Sleeve Gastrectomy

The Titan SGS design ensures more consistent staple formation across the entire 23-centimeter cutline.

PR Newswire 07.02.21

R&D & Design

Medical Device Development: Three Tips for Success

Analyzing the design phase of the medical device development process.

Shrinidh Joshi, medtech consultant on Kolabtree 07.01.21

Diagnostics

Global POC Diagnostic, Testing Market to Top $34B by 2027

The advent of advanced technologies, a growing geriatric population, and the rising prevalence of infectious as well as chronic diseases will help drive growth.

Globe Newswire 07.01.21

Solid Growth Anticipated for Global Sleep Apnea Diagnostics Market

Sector is expected to swell nearly 7 percent annually through 2027.

Globe Newswire 07.01.21

Safeguard Medical Buys PerSys Medical

Brings broadest portfolio of life-saving medical equipment, tech, services to first responders.

PR Newswire 07.01.21

Ultra-Fast COVID-19 Antibody Test Under Development

Test could be used worldwide to help prioritize who should receive coronavirus vaccines.

Business Wire 07.01.21

Diagnostics

How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests

Leveraging technology to improve speed to market without sacrificing quality.

Brandon Henning, VP of Product at Greenlight Guru 07.01.21

Surgical

The Future of AI and OR Medical Devices

Bringing artificial intelligence to the operating room.

Michael Hutton, Upper GI Specialist at Royal Cornwall Hospitals NHS Trust 06.30.21

Cardiovascular

The Reemergence of Pulsed Field Ablation in Cardiac Electrophysiology

Reviewing the innovative technology’s history and impact on persistent atrial fibrillation.

Steven Mickelsen, MD, Chief Translational Science Officer, Acutus Medical 06.29.21

Diagnostics

Interventional Systems’ Miniature Medical Robot Cleared by FDA

Makes way for the European company to start building its U.S. presence.

Interventional Systems 06.29.21

Excelitas Technologies To Acquire PCO AG

PCO’s scientific CMOS camera technologies for high-performance imaging will enhance Excelitas’ photonics portfolio.

Excelitas Technologies Corp. 06.29.21

TÜV SÜD North America Gains FDA Accreditation for Device Testing

TÜV SÜD offers ASCA-accredited laboratory testing of medical devices at five U.S. locations and in Canada.

Business Wire 06.29.21

Cardiovascular

FDA Approves AtriCure's EPi-Sense System for Persistent Afib

Trial showed a 29 percent difference in effectiveness at 12 months, a 35 percent difference in effectiveness at 18 months for long-standing persistent Afib.

Business Wire 06.29.21

Digital Health

Canon Medical Expands AI-Based Image Reconstruction Tech

AiCE) Deep Learning Reconstruction can now be used for 96 percent of all procedures using the Vantage Galan 3T MR system.

Business Wire 06.29.21

Diagnostics

Abbott's Panbio Rapid COVID-19 Antigen Self-Test Earns EU Approval

Approved for sale directly to consumers and for use in adults and children with or without symptoms.

Abbott Laboratories 06.28.21

Wellesley College President Joins Abiomed Board of Directors

Paula A. Johnson, M.D., also was a professor of medicine at Harvard Medical School.

Business Wire 06.28.21

Cardiovascular

Paragonix Study Shows Improved Outcomes for Heart Transplant Patients

Donor hearts preserved by the company's SherpaPak had statistically significant increases in total ischemic time and travel distance.

Business Wire 06.28.21

COVID-19 Sample Collection Kits Market to Reach $16.56B by 2028

Most lucrative growth to occur in Asia Pacific region.

Polaris Market Research 06.28.21

A wide variety of high-performance drives

maxon, high precision drive specialist, launches high-torque product innovations this Spring.

New miniature drives for medical robots and multi-axis systems

maxon is once again expanding its range of configurable drives with more brushless DC motors, gearheads, and encoders from the ECX series.

maxon Partners with Open-Source Champion Auterion to Galvanize Drone Industry

Strategic partnership will offer industry changing avionics and propulsion system integration for software-defined drones that mark future of drone scaling.

Positioning controller with extreme power density

The EPOS4 micro 24/5 EtherCAT is the latest addition to the maxon family of positioning controllers.

«driven» takes a look at the fourth planet

Our fascination with Mars is stronger than ever, again and again, researchers are drawn to it.

Surgical

Medtronic’s Hugo Robotic Surgery System Makes Clinical Debut

The robotic prostatectomy marked the start of the Hugo RAS System global patient registry.

PR Newswire 06.23.21

Digital Health

Pear Therapeutics to Become Public Company

Seeks to expand its leadership position in prescription digital therapeutics.

Pear Therapeutics 06.23.21

Canada Approves Drug-Releasing Contact Lens for Eye Allergies

Daily disposable lens corrects vision and provides relief to patients suffering from allergic conjunctivitis.

PR Newswire 06.23.21

Diagnostics

DARPA Enlists University to Develop AI for Portable Ultrasound

Research team will put expert knowledge at the fingertips of frontline medics.

Carnegie Mellon University 06.22.21

MedTech Innovator Selects 20 Firms for Asia Pacific Accelerator

Finalist companies comprised of promising entrepreneurs from the Asia Pacific Region.

Business Wire 06.22.21

Abbott Engages in STEM Internships for College Credit

First-of-its-kind college credit opportunity provides model other companies can follow to give students a head start on earning STEM degrees.

PR Newswire 06.22.21

Second U.S. Patent Awarded to Alvalux for Wearable Light Therapy Device

Company received its first patent earlier this year for a wearable dermal repair system marketed under the CicaLux brand.

PR Newswire 06.21.21

Baxter Receives Grant to Lead Extracorporeal Blood Purification Research

Company will focus on enabling more selective approaches for certain extracorporeal blood purification therapies.

Business Wire 06.18.21

QIAGEN Launches Technology to Triple COVID-19 Lab Testing Capacity

The innovation integrates sample preparation and detection in a single kit, enabling throughput of more than 670 tests per PCR cycler in an eight-hour shift.

Business Wire 06.15.21

Philips Recalls Certain Sleep and Respiratory Care Devices

Mitigates potential health risks related to the sound abatement foam component.

GlobeNewswire 06.14.21

Surgical

Aspen Surgical Buys Stork Labor and Delivery Products

Provides a platform for growth in obstetrics and gynecology.

Business Wire 06.14.21

Vivasure Medical First Patient in Study of Next-Gen PerQseal+ Device

Trial will provide investigators with a better understanding of the product's benefits.

Michael Barbella 06.14.21

NanoVibronix Begins Real World Patient Study of UroShield

Patient recruitment underway; interim results expected in October.

Business Wire 06.11.21

Tubing & Extrusion

Zeus Acquires CathX Medical

Will integrate the catheter-based contract manufacturer.

Zeus Industrial Products Inc. 06.10.21

Cardiovascular | Surgical

FDA Clears Neurescue's Intelligent Balloon Catheter

Cleared for hemorrhage control and IDE approved for cardiac arrest.

Business Wire 06.10.21

Patient Monitoring

Xandar Kardian’s Health Monitoring Radar Gains Clearance

This radar people-counting solution enables continuous and completely autonomous vital sign readings in real-time

Xandar Kardian 06.10.21

Patient Monitoring

FDA OKs Canon Medical's Digital PET/CT for AI-Based Image Reconstruction

Cartesion Prime with AiCE helps clinicians produce high-quality images consistently.

Business Wire 06.10.21

Oak Hill Capital Buys Majority Stake in Technimark

Acquisition gives Oak Hill a controlling stake in the firm, forming a partnership with the current investors.

PR Newswire 06.08.21

Software & IT

How Digitization Enables Safe, Connected Operations in Manufacturing

In a post-pandemic world, it’s time for companies to address the weaknesses revealed from the experience.

David Butcher, Staff Writer, MasterControl 06.08.21

Cardiovascular | Surgical

Medtronic Reveal LINQ ICM Trial Data Shows Superiority

Demonstrated seven-fold increase in detecting atrial fibrillation vs. standard of care.

Sam Brusco, Associate Editor 06.08.21

Private Equity Group to Buy Medline for Over $30B

Medline will remain a privately held, family-led company.

Sam Brusco, Associate Editor 06.07.21

Global Diabetes Care Devices Market to Garner $39.4B by 2027

The increasing geriatric population is forecast to drive market growth over the next six years.

Michael Barbella, Managing Editor 06.07.21

Intertek Granted ASCA Recognition by FDA for Medical Device Premarket Testing

he ASCA Pilot Program is a voluntary program developed to provide increased confidence in testing results.

Michael Barbella, Managing Editor 06.04.21

CeQur Raises $115 Million Series C5 Financing

Money will support the commercialization and scale-up of automated manufacturing for the firm's Simplicity wearable insulin delivery device.

Michael Barbella, Managing Editor 06.04.21

Cardiovascular | Software & IT

GE Healthcare, ACC Team Up to Advance AI in Cardiac Care

Collaboration will start tackling overwhelming challenges related to AFib management.

Sam Brusco, Associate Editor 06.03.21

Cardiovascular | Patient Monitoring

AliveCor Buys CardioLabs, an Independent Dx Testing Firm

Sets stage for launch of advanced ambulatory monitoring services.

Sam Brusco, Associate Editor 06.03.21

Cardiovascular | Digital Health | Software & IT

FDA Clears Avicenna.AI's Triage Solution for Deadly Vascular Conditions

CINA CHEST detects and supports emergency triage of pulmonary embolism and aortic dissection.

Sam Brusco, Associate Editor 06.02.21

Patient Monitoring

BioBeat Rolls Out Wearable Continuous Ambulatory Blood Pressure Monitoring Device

New clinical data supports use of Biobeat ABPM cuffless-monitor as reliable and accurate solution for out-of-clinic blood pressure monitoring.

Charles Sternberg, Assistant Editor 06.02.21

Will Recent Changes in CMS Rules Sink Us?

As of Jan. 1, CMS started cutting its list of inpatient-only services.

Dawn A. Lissy, Founder & President, Empirical 06.02.21

Chronic Disease

Ibex Medical Analytics Earns CE Mark for Galen Breast Solution

Demonstrates very high accuracy in detecting multiple types of breast cancer in a blinded study.

Charles Sternberg, Assistant Editor 06.01.21

Memic Innovative Surgery Raises $96 Million

Funding will primarily support commercialization of the Hominis surgical robot in the United States.

Michael Barbella, Managing Editor 06.01.21

Contract Manufacturing

Maintaining Quality in the Fast-Paced Contract Manufacturing Industry

A cautionary tale from pharma offers lessons to device manufacturers about the dangers of a quality system that isn’t digital.

Dale Thompson, Staff Writer, MasterControl 05.27.21

Flambeau Inc. Invests in Operations

Adds new presses at three of its North American plants.

Charles Sternberg, Assistant Editor 05.27.21

Digital Health

Philips, Ibex Medical Analytics Partner to Accelerate Adoption of AI-Powered Digital Pathology

Combination of Philips’ digital pathology solutions and Ibex’s AI-powered Galen platform has improved reporting efficiency by 27 percent.

Michael Barbella, Managing Editor 05.27.21

amg International Receives CE Mark for Unity-B Biodegradable Stent

Compliments Archimedes, amg’s CE approved pancreaticobiliary biodegradable implant.

Charles Sternberg, Assistant Editor 05.26.21

Your Most Trusted R&D Testing Partner

Bringing innovative medical device technology to the marketplace is a high risk venture.

BD to Build $200 Million Manufacturing Facility in Zaragoza, Spain

Construction of the new plant will begin in late 2021.

Charles Sternberg, Assistant Editor 05.18.21

Olive Union Raises $20 Million to Expand into Digital Hearing Therapeutics

The global smart hearing aid startup is developing new digital therapies for tinnitus and overall hearing health.

Michael Barbella, Managing Editor 05.18.21

FDA Clears Nanox's Single-Source Digital X-Ray

Company's technology digitally generates electrons and successfully replaces the thermionic filament ‎in the X-ray tube.

Michael Barbella, Managing Editor 05.17.21

Quidel Granted EUA to Market COVID-19 Antigen Test

Assay provides results in 15 minutes and s now available without a prescription.

Michael Barbella, Managing Editor 05.17.21

Cardiovascular | Surgical

Abbott's Navitor TAVI System Gains CE Mark

The new TAVI system features advancements to reduce or eliminate risk of blood leakage around valve implant.

Sam Brusco, Associate Editor 05.17.21

Hologic Launches Project Health Equality

Aims to address the barriers that prevent Black and Hispanic women in the U.S. from receiving the same quality health care as white women.

Charles Sternberg, Assistant Editor 05.17.21

Neurological

Rice Researchers Seek to Create an Implant That Controls the Body’s Circadian Clock

Could halve the time it takes to recover from jet lag and similar disruptions to the body's sleep/wake cycles.

Charles Sternberg, Assistant Editor 05.14.21

Electronics

Miniaturizing Linear Motion and Measurement—A Medical Equipment Challenge

A real world example of a successful engineering challenge to develop a smaller, lighter motion control solution.

Christian Meier, Senior Product Manager, SCHNEEBERGER 05.14.21

Diagnostics

BD Announces CE Marked Assay for HPV Screening from At-Home Self-Collected Samples

Affords women greater access to testing.

Charles Sternberg, Assistant Editor 05.14.21

Tech Etch Appoints Brian Roberts as CFO

Roberts brings 25 years of extensive international financial and operational experience.

Charles Sternberg, Assistant Editor 05.14.21

Two Sublime Radial Access Platform Devices Used for First Time in Patients

Surmodics' Sublime Radial Access .014 RX PTA Dilatation Catheter, Sublime Radial Access Guide Sheath deliver solid performance.

Michael Barbella, Managing Editor 05.14.21

Contract Manufacturing

Empowering Connected Medtech Manufacturing Workers

With a worker shortage on the horizon and lessons learned from the pandemic, connected workers could help ease the challenges ahead.

Louis Columbus, Enterprise Software Strategist, DELMIAWORKS 05.13.21

Contract Manufacturing

A Contract Manufacturer Selection Handbook

This article will offer considerations and best practices for selecting the right partner for your medical device development project.

Ashley Turrell, Director of Strategy, Natech Plastics 05.13.21

Digital Health

Empowering Value-Based Care Through Interoperability

EHR interoperability and medical device connectivity enable healthcare providers to meet the shift toward value-based care and reimbursement.

Josh Hetler, Executive Vice President, Business Intelligence, DataLink 05.13.21

MDS Acquires Assets of APS Plastics and Manufacturing

Expands its machining capabilities.

Charles Sternberg, Assistant Editor 05.12.21

Diagnostics

Olympus Releases New Endobronchial Ultrasound Bronchoscope

The BF-UC190F aids physicians in diagnosing and staging lung cancer without surgery.

Sam Brusco, Associate Editor 05.12.21

J&J Vision ACUVUE Abiliti Overnight Lenses for Myopia Earn FDA Approval

First and only FDA-approved orthokeratology contact lens for myopia management, according to company.

Sam Brusco, Associate Editor 05.12.21

Surgical

Olympus Rolls Out Airway Mobilescopes

All-in-one design allows a range of recordable, sharable airway management procedures.

Sam Brusco, Associate Editor 05.12.21

Double-Digit Growth Expected for South Korean Coronary Stents Market

Increase to be driven by improved outcomes of stenting procedures and lower prices.

Michael Barbella, Managing Editor 05.12.21

FDA Grants EUA to Beckman Coulter's COVID-19 Antibody Test

Assay being rolled out in laboratories throughout the New York City metropolitan area.

Michael Barbella, Managing Editor 05.11.21

Patient Monitoring

Medtronic Rolls Out SonarMed Pediatric Monitor

Alerts clinicians to potential airway obstructions during ventilation.

Sam Brusco, Associate Editor 05.10.21

Neurological

Theranica’s Therapeutic Wearable Wins Award

Nerivio was named as the ‘Best New Technology Solution for Pain Management.’

Charles Sternberg, Assistant Editor 05.07.21

Surgical

FDA Approves J&J Vision's TECNIS Synergy, Synergy Toric II IOLs

Next-generation presbyopia-correcting intraocular lens (PCIOL) also approved in Canada.

Sam Brusco, Associate Editor 05.07.21

GORE Reports First Use of the EXCLUDER Conformable AAA Endoprosthesis

Cases successfully performed in Brooklyn, N.Y., and Houston.

Michael Barbella, Managing Editor 05.07.21

Chronic Disease

BD to Spin Off Diabetes Care Biz

Transaction is expected to be completed in the first half of 2022.

Sam Brusco, Associate Editor 05.06.21

FDA Policy Supports the Use of Dry Heat Systems in the Processing of N95 Masks

Allows Tenney Environmental to supply equipment in the fight against COVID-19.

Charles Sternberg, Assistant Editor 05.06.21

FDA Approves Helius Medical's Stimulator Device for Gait Improvement

The product is a short-term treatment for gait deficit as a result of mild to moderate symptoms from multiple sclerosis.

Michael Barbella, Managing Editor 05.06.21

PolyVascular Awarded $2 Million Grant to Study Pediatric Heart Valve

Company hires Will Clifton as COO to manage the path to human trials in the United States.

Michael Barbella, Managing Editor 05.06.21

Stephanie Fehr Appointed to Invacare Corporation's Board

New addition currently works for UnitedHealthcare and spent nearly two decades at Apple Computer Inc.

Michael Barbella, Managing Editor 05.05.21

Study Shows High Safety, Efficacy for Adjustable Thrombectomy Device

Data demonstrate 84.6 percent revascularization success with Rapid Medical’s TIGERTRIEVER.

Michael Barbella, Managing Editor 05.04.21

Outset Medical Appoints Andrea Saia to Board of Directors

New member has focused her 40-year career building leading global brands in the consumer products and medical technology businesses.

Michael Barbella, Managing Editor 05.04.21

Cardiovascular | Surgical

Medtronic's Evolut PRO+ TAVI System Gains CE Mark

PRO+ TAVI System launches with four valve sizes and lowest delivery profile yet.

Sam Brusco, Associate Editor 05.04.21

Surgical

FDA Clears XPERIENCE No Rinse Antimicrobial Solution

The solution defends against germs for hours and can used in virtually every open surgery case.

Michael Barbella, Managing Editor 05.04.21

Digital Health

How Can a Device End User Aid in Cybersecurity?

MPO's Sean Fenske gets tips from Alan Grau of Sectigo about how a medical device end user, whether physician or patient, can help ensure the unit is secure.

Sean Fenske, Editor-in-Chief

Preparing for the EU’s MDR

As the clock to the deadline is in the final minutes, this article offers a few tips to help ensure companies meet with the requirements.

Nick Tippmann, Vice President of Marketing, Greenlight Guru 04.29.21

Materials

The Plastics Problem—Infection Control vs. Medical Equipment

Due to harsh chemicals, medical device manufacturers need a solution to the problems caused by regular cleaning of healthcare equipment.

Ryan Hoobler, VP of Engineering, Code Corporation 04.29.21

Neurological

Medtronic's TNM Implant Study for Bladder Incontinence Gets FDA Nod

Implantable tibial neuromodulation (TNM) therapy will be evaluated for symptom relief.

Sam Brusco, Associate Editor 04.27.21

Cardiovascular

Ceryx Medical Appoints Chas Taylor as Chairman

New leader founded three international cardiovascular businesses.

Michael Barbella, Managing Editor 04.27.21

Neurological

LivaNova, Verily Begin Difficult-to-Treat Depression Study

Verily research tools will evaluate real-world VNS Therapy effectiveness as adjunctive difficult-to-treat depression treatment.

Sam Brusco, Associate Editor 04.27.21

LG Expands Diagnostic Medical Monitor Line

Unveils new 12-megapixel multimodality display.

Charles Sternberg, Assistant Editor 04.23.21

Digital Health

What Could Medical Device Hacking’s Future Look Like?

MPO's Sean Fenske and Alan Grau of Sectigo discuss potential hacking strategies for future instances of gaining access to medical technology.

Sean Fenske, Editor-in-Chief

Electronics

OEMs Increasingly Choosing EMS Providers Closer to Home

Firstronic CEO notices preference among major device firms to reshore electronics manufacturing.

Michael Barbella, Managing Editor 04.23.21

Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry

Prevalence of critical congenital heart disease in the Sri Lankan study was 2.02 per 1,000 live births.

Michael Barbella, Managing Editor 04.22.21

Patient Monitoring

FDA Grants 510(k) Clearance to LivaNova’s B-Capta

An in-line, blood-gas monitoring system integrated into the S5 Heart-Lung Machine.

Charles Sternberg, Assistant Editor 04.20.21

Gynesonics Appoints Susan Stimson to Its Board of Directors

Executive with extensive commercialization experience to provide key insights on global launch strategies.

Michael Barbella, Managing Editor 04.20.21

Cardiovascular

Riva Health Raises $15.5 Million for Breakthrough Mobile Cardiology Technology

Menlo Ventures, UCHealth invest to bring comprehensive hypertension measurement and management to the phone.

Michael Barbella, Managing Editor 04.20.21

Diagnostics

Abbott Begins Shipping Rapid COVID Self-Tests

Abbott to manufacture tens of millions of BinaxNOW Self Tests per month.

Sam Brusco, Associate Editor 04.20.21

Electronics

EMS' Engineering Resources Increasingly in Demand

Unpredictable demand, the need to reduce costs, and shorter production lead times driving companies to seek earlier interaction with product engineers.

Michael Barbella, Managing Editor 04.20.21

NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite

Mobile Stroke Unit includes new CT scanner and features that help EMTs improve patient care.

Michael Barbella, Managing Editor 04.19.21

Digital Health

Real-World Medical Device Hacking Tales

MPO's Sean Fenske gains some insights from Alan Grau of Sectigo on examples of real-world healthcare device hacking incidents and the details involved.

Sean Fenske, Editor-in-Chief

Iterative Scopes Announces IBD-Focused Scientific Advisory Board

The governing body also will include experts in artificial intelligence.

Michael Barbella, Managing Editor 04.16.21

Electronics

Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics

Devices with high-speed data capabilities and high-resolution video must be rugged enough to withstand OR environment and harsh sterilization methods.

Michael Barbella, Managing Editor 04.15.21

Thermo Fisher Scientific to Acquire PPD for $17.4 Billion

The deal establishes Thermo Fisher as a global leader in the high-growth clinical research services industry.

Michael Barbella, Managing Editor 04.15.21

Portable Medical Devices Market to Reach $100 Billion by 2027

Sector to grow 8.5 percent annually over the next six years, driven by an increased awareness of overall health and fitness.

Michael Barbella, Managing Editor 04.15.21

Chronic Disease

BD Receives 510(k) Clearance for Pristine Catheter

The clearance was supported by clinical data from a feasibility study with favorable primary patency rates observed out to 180 days.

Charles Sternberg, Assistant Editor 04.15.21

Chronic Disease

Medtronic Introduces Extended Infusion Set in Europe

Can be worn for up to seven days so users can safely stay on insulin pump therapy with fewer interruptions and insertions.

Charles Sternberg, Assistant Editor 04.14.21

Cardiovascular | Software & IT

BioSig Launches Software Update for PURE EP Electrophysiology Platform

The upgrade includes enhanced signal processing for advanced cardiac signal analysis.

Sam Brusco, Associate Editor 04.14.21

Surgical

Katena Acquires Ophthalmic Surgical Instrument Maker ASICO

Katena obtains high-quality ophthalmic surgical instruments.

Sam Brusco, Associate Editor 04.14.21

Nagarro Achieves ISO 13485 Certification

Company's iife sciences and healthcare business unit offers new opportunities in digital disruption and connected medical devices.

Michael Barbella, Managing Editor 04.14.21

MICRO Expands with New Facility in Costa Rica

Increases its cleanroom assembly capacity to better serve its medical device customers.

Charles Sternberg, Assistant Editor 04.13.21

Cardiovascular

Endologix Acquires PQ Bypass

Gains proprietary Detour platform for percutaneous femoral-popliteal bypass.

Sam Brusco, Associate Editor 04.13.21

Cardiovascular

Elixir Medical Begins Study of Metallic Implant for CAD Treatment

Product is designed to adapt to vessel physiology.

Michael Barbella, Managing Editor 04.13.21

CMS Establishes New Payment for Pelvalon’s Eclipse System

Enables women access to a life-changing therapy for loss of bowel control.

Charles Sternberg, Assistant Editor 04.09.21

Chronic Disease | Software & IT

Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy

Firms will collaborate to build AI tools for radiation oncology organ segmentation using the Google Cloud AI Platform.

Sam Brusco, Associate Editor 04.09.21

Software & IT

Three Future Trends and Opportunities in Quality Assurance

As regulated companies, medical device firms must stay abreast of the latest developments to ensure they adopt new protocols to maintain quality assurance.

David Jensen, Staff Writer, MasterControl 04.09.21

Software & IT

Adopting a Data-Driven Quality Model

Employing a data-driven quality model helps you apply quality processes more holistically throughout the organization.

David Jensen, Staff Writer, MasterControl 04.09.21

Cardiovascular

USPTO Issues Patent Covering Hancock Jaffe’s VenoValve

Valve is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency (CVI).

Charles Sternberg, Assistant Editor 04.08.21

Viant Completes Expansion of Costa Rica Facility

New capabilities will boost speed to market for complex medical devices.

Charles Sternberg, Assistant Editor 04.08.21

Cardiovascular

Digging into the Cardiac Arrhythmia Monitoring Device Market

The overall market is set to reach an annual valuation of $9 billion by 2026.

Saloni Walimbe, Research Content Developer, Global Market Insights 04.08.21

SMC Ltd. Expands Costa Rica Facility

Doubles the current facility, bringing it to 120,000 square feet in the Coyol Free Zone Park in Alajuela, Costa Rica.

Charles Sternberg, Assistant Editor 04.07.21

J&J Vision, Menicon Begin Myopia Contact Lens Making Partnership

The firms aim to bring forward a portfolio of products and services to manage myopia progression in children.

Sam Brusco, Associate Editor 04.07.21

Berlin Heals' C-MIC Heart Failure Implant Achieves Breakthrough Device Status

Company initiates an early feasibility study in the United States.

Michael Barbella, Managing Editor 04.07.21

Digital Health

Cloud and AI Accelerating Global Medical Imaging Informatics Market

Modern informatics solutions will drive revenue in developed markets, according to Frost & Sullivan.

Michael Barbella, Managing Editor 04.07.21

Grant Issued for Development of 3D-Printed Resorbable Medical Implants

BellaSeno and Fraunhofer Institute for Production Technology are partnering on the innovation.

Michael Barbella, Managing Editor 04.05.21

Philips Survey Reveals COVID-19’s Negative Impact on Sleep Quality, CPAP Use

Seventy percent of people surveyed have experienced one or more new sleep challenges since the start of the pandemic, data show.

Michael Barbella, Managing Editor 04.05.21

Second Sight Aborts Business Combination with Pixium Vision

Pixium said it would take all necessary means—including legal measures—to claim compensation.

Sam Brusco, Associate Editor 04.05.21

Cardiovascular

Cardiovascular Device Market Expands to Tackle Higher Disease Burden

The market is likely to exceed a valuation of $10 billion by 2027.

Vinisha Joshi, Research Content Developer, Global Market Insights 04.01.21

Chronic Disease | Digital Health | Patient Monitoring

CGM: Digital Health Meets a Very Large Opportunity

Continuous glucose monitors (CGMs) are one of the most formidable diabetes management tools to be developed in decades.

Maria Shepherd, President and Founder, Medi-Vantage 04.01.21

Molding | Surgical

Optimizing MIM in Medical Device Manufacturing

Metal injection molding (MIM) is a good choice for producing medium- to high-volume medtech parts.

Steve Santoro, Executive Vice President, MICRO 04.01.21

Diagnostics

PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market

With smart onshoring strategies, the medical device industry can collaborate to fix supply chain issues.

Claudio Hanna and Ralph Tricomi , Web Industries 04.01.21

Testing

The Evolution of Chemical Characterization for Medical Devices

Evaluation of biological safety of devices is experiencing some of the most significant changes in history.

Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Medical Device Testing 04.01.21

Digital Health

How Digital Health Fits into the Medtech Mold

Healthcare will need to adopt digital technologies that streamline and enhance connectivity.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 04.01.21

Global Supply Chain Wisdom from Coronavirus-Colored Lenses

There are precious pearls of wisdom from this past year that will come in handy during the next “crisis.”

Chris Oleksy, Founder and CEO, Oleksy Enterprises and Co-Founder Next Life Medical; CEO, Emergent Respiratory 04.01.21

Four Considerations When Selling to a Private Equity Fund

A private equity partner can help medtech firms expand into new markets and serve existing clients better.

Bill Hadler and Anisa Mohanty, McDermott Will & Emery 04.01.21

The Reality of Virtual Experiences for Medtech

VR presents a great way to expose doctors and other medical professionals to new technologies.

Sean Fenske, Editor-in-Chief 04.01.21

Contract Manufacturing | Software & IT | Testing

Quality & Regulatory Solutions for the FDA Regulated Industries

EMMA International specializes in full-circle solutions for the medical device, biologics, and pharma industries.

Longeviti Launches ClearFit Covers for Brain Surgery Patients

ClearFit Implants can reconstruct the skull and be used as a diagnostic tool.

Michael Barbella, Managing Editor 04.01.21

Diagnostics

Abbott's Rapid COVID-19 Self-Test Receives EUA

Permits asymptomatic, non-prescription, over-the-counter self-use for people with or without symptoms.

Sam Brusco, Associate Editor 04.01.21

Fralock Holdings Acquires Oasis Materials

Third strategic acquisition in 12 months expands Fralock Holdings' solutions across critical industries.

Michael Barbella, Managing Editor 04.01.21

ForSight Robotics Raises $10 Million in Seed Round

Company's platform aims to automate the complex subtleties of ophthalmic surgery with an intuitive, patient-centric system.

Michael Barbella, Managing Editor 04.01.21

Diagnostics

Diagnosing the IVD Market: An Interview with TEAM Technologies

Chief revenue officer Steve Lents discusses the in-vitro diagnostic market and manufacturing rapid antigen POC COVID-19 tests.

Sam Brusco, Associate Editor 03.30.21

Why Is Manufacturing Demand Increasing for IV Bags?

Many types and sizes of IV bags are in short supply, putting a strain on the industry.

Emily Newton, Editor-in-Chief, Revolutionized 03.30.21

Jabil Healthcare, E3D Collaborate on Drug Delivery Device Tech

Agreement provides Jabil with exclusive license to develop drug delivery device product platform based on E3D mechanical multi-use auto-injector technology.

Michael Barbella, Managing Editor 03.30.21

Ultrasound Stimulation Can Reduce Obesity, Research Indicates

New study is based on the discovery that ultrasound can be used to perform peripheral nerve modulation as a new form of bioelectronic medicine.

Michael Barbella, Managing Editor 03.29.21

Access Vascular Secures $20 Million in Series B Financing

Money will be used to generate post-market data on two commercial devices designed to reduce thrombus accumulation and catheter occlusions.

Michael Barbella, Managing Editor 03.29.21

Cardiovascular

FDA Approves Medtronic's Harmony TPV for Congenital Heart Disease

Less invasive option to treat pulmonary valve regurgitation for patients with a native or surgically-repaired right ventricular outflow tract.

Sam Brusco, Associate Editor 03.26.21

Software & IT

Using Quality as an Advantage in 2021

Report finds despite pandemic, 79 percent of medical device professionals expect modest or strong revenue growth in 2021.

Jon Speer, Founder, Greenlight Guru 03.25.21

Diagnostics

FDA OKs GE Healthcare's New 3D Surgical Imaging System

OEC 3D brings precise 3D and 2D imaging to surgical suites, improving efficiency.

Sam Brusco, Associate Editor 03.25.21

CareSignal Expands its Deviceless Remote Patient Monitoring System

Deloitte collaboration supports healthcare organizations offering virtual patient care.

Michael Barbella, Managing Editor 03.25.21

Philips Partners With DiA Imaging Analysis to Enhance Ultrasounds

New AI technology automates the process of manually capturing and visually analyzing ultrasound images.

Michael Barbella, Managing Editor 03.25.21

Masimo's Rad-G With Temperature Earns CE Mark

Rad-G can be converted from a handheld spot-check device into a continuous monitoring device, in the absence of other multi-parameter monitors.

Michael Barbella, Managing Editor 03.24.21

J&J Executive, CNN On-Air Commentator Appointed to Glaukos Board

With latest additions, the governing body now consists of nine directors.

Michael Barbella, Managing Editor 03.24.21

Tissium Appoints VP of Global Operations

Thierry Darnis brings a deep background as a global leader managing major medical device design and production units at world-class companies.

Charles Sternberg, Assistant Editor 03.23.21

Software & IT

5 Ways Manufacturers Can Improve IoMT Device Security

Manufacturers cannot make development and security mistakes with IoMT devices.

Emily Newton, Editor-in-Chief, Revolutionized 03.23.21

Diagnostics

Optellum Receives FDA Clearance for Virtual Nodule Clinic

Empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is now commercially available in the U.S.

Charles Sternberg, Assistant Editor 03.23.21

Chronic Disease

Insulet’s Omnipod 5 Shows Promise in Pivotal Trial

Demonstrated improved clinical outcomes in type 1 diabetes.

Sam Brusco, Associate Editor 03.23.21

Contract Manufacturing | Molding

Medtech Makers: Molding Validation Optimization

PTI’s Steve VanderKooi offers advice to help manufacturers avoid pitfalls and delays to ensure a timely and repeatable validation protocol.

U.S. Safety Needles Market to Top $3.4B by 2028

Favorable government reimbursement for pen needles is expected to help drive the market.

Michael Barbella, Managing Editor 03.19.21

Chronic Disease

FDA Approves Boston Scientific's TheraSphere Y-90 Glass Microspheres

The only radioembolization treatment approved for U.S. patients with hepatocellular carcinoma.

Sam Brusco, Associate Editor 03.18.21

Olympic Bobsledder Named New Board Chairman at PathogenX

World Cup medalist has spent half his sales and management career in the medical device and healthcare technology sector.

Michael Barbella, Managing Editor 03.18.21

Diagnostics

GE Healthcare Reveals Vscan Air Wireless, Handheld Ultrasound

Touts dual-probe whole-body scanning capabilities.

Sam Brusco, Associate Editor 03.17.21

SIA Enrolls First Patient in Study of its Surgical Mesh for Breast Reconstruction

The product is made from a biocompatible synthetic material to provide mechanical support and scaffolding.

Michael Barbella, Managing Editor 03.17.21

Hearing Implant Market Value to Expand by $600M This Decade

Sector will be driven by an increasing prevalence of hearing loss among the world's aging populations.

Michael Barbella, Managing Editor 03.17.21

Catheter and Medical Design Acquires VitalDyne Medical Inc.

Provides customers with greater speed, flexibility, and value.

Charles Sternberg, Assistant Editor 03.16.21

The Many Hats of an Integrated Contract Manufacturer

and How Each One Fortifies Your Medical Device Supply Chain

Medical Device Supply Chain: At What Stage of a Product’s Lifecycle Should You Bring in a CM Partner

Your contract manufacturing partner can have a dramatic effect on the success (or failure) of your project.

Software & IT

Three Reasons Automation and Training Are Essential in Your MDQMS

Having the proper tools in place to ensure all training activities are occurring when and how they should is critical to quality.

Jon Speer, Founder, Greenlight Guru 03.15.21

Testing

NAMSA Appoints New CEO, Board Chairman

Dr. Christophe Berthoux will begin leading the company March 22; former AdvaMed Chairman Nadim Yared to become NAMSA Chairman.

Sam Brusco, Associate Editor 03.15.21

FDA Clears Rhythmlink's New MR Conditional Electrode Portfolio

Sticky Pad Electrode line now boasts MR conditional clearance and CT compatibility.

Michael Barbella, Managing Editor 03.15.21

LifeTech Technology for Life Sciences

Life sciences – smart solutions for medical technology and laboratory automation

Control Under Pressure

How to use pneumatic technology to build high-performance liquid dispensing systems for lab automation applications

In vitro diagnostics Automation of point-of-care devices

Get ready for market launches faster by working together to develop ready-to-install automation solutions.

Cardiovascular

Cardinal Health to Sell Cordis Biz to Hellman & Friedman for $1B

Transaction is expected to close in the first half of Cardinal Health's fiscal year 2022.

Sam Brusco, Associate Editor 03.12.21

Cardiovascular

Global Cardiovascular Devices Market to Exceed $62 Billion by 2025

Sector to be driven in part by the robust performance of cardiac assist products.

Michael Barbella, Managing Editor 03.12.21

TransEnterix Establishes European Training Center

Netherlands site will provide basic and advanced training on the Senhance Surgical System.

Michael Barbella, Managing Editor 03.11.21

Neurological

Abbott Releases NeuroSphere Virtual Clinic for Remote Neuromodulation Care

Patients can communicate with a physician and remotely receive stimulation settings in real-time with a web connection.

Sam Brusco, Associate Editor

Diagnostics

EchoNous Expands Its Kosmos Hardware Platform

Adds continuous wave and pulsed wave Doppler capabilities.

Charles Sternberg, Assistant Editor 03.04.21

FDA Making Progress With Technology and Data Action Plans

There is an urgent need to get advanced technologies into the healthcare ecosystem, but all products must first get regulatory approval.

Alan Rencher, Vice President, Engineering, MasterControl 03.04.21

NAMSA Acquires American Preclinical Services

Enhances its preclinical solutions with a broader range of laboratory models and analysis tools.

Charles Sternberg, Assistant Editor 03.02.21

Surgical

Memic Receives FDA Marketing Authorization for Hominis

Its robot-assisted surgical platform is now available for use in transvaginal gynecologic procedures including benign hysterectomy.

Charles Sternberg, Assistant Editor 03.02.21

Varian CEO to Retire Following Siemens Healthineers Acquisition

Dow Wilson will be succeeded by Varian president and COO Chris Toth, who will lead Siemens' Varian business segment.

Sam Brusco, Associate Editor 03.02.21

FDA Breakthrough Device Designation Awarded to BrainCool AB's Cooral System

The Cooral System was CE marked in June 2020 as an invasive medical device.

Michael Barbella, Managing Editor 03.02.21

Axonics Buys Contura to Expand to Stress Urinary Incontinence

Gains Bulkamid, a urethral bulking agent for women.

Sam Brusco, Associate Editor 03.01.21

First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

The product received CE Mark approval in January.

Michael Barbella, Managing Editor 02.26.21

Millstone Medical Outsourcing Reaches 600-Employee Milestone

Posts year-over-year growth of 16% in its 20th year of business.

Charles Sternberg, Assistant Editor 02.23.21

FDA Approves Daytime Treatment for Sleep Apnea and Snoring

Signifier Medical’s proprietary therapy eXciteOSA is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology approved in the U.S.

Michael Barbella, Managing Editor 02.23.21

Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S.

Provides respiratory support for patients with COVID-19 and other respiratory conditions.

Sam Brusco, Associate Editor 02.23.21

Trademark Plastics Inc. Partners with MedAccred

Reaffirms its commitment to complete quality assurance.

Charles Sternberg, Assistant Editor 02.19.21

Flywheel Secures $15 Million in Series B Funding

The funding will allow the company to deepen its presence in the life sciences and AI markets.

Michael Barbella, Managing Editor 02.19.21

FDA Clears B-Secur's HeartKey EKG/ECG Technology

The product's algorithms can be quickly integrated in semiconductors for devices in the medtech, health monitoring, and wellness sectors.

Michael Barbella, Managing Editor 02.19.21

Diagnostics

Study Validates Vocalis Health’s COVID-19 Screening Tool

VocalisCheck obtains CE mark approval for medical use.

Charles Sternberg, Assistant Editor 02.18.21

Bicuspid Aortic Stenosis Treatment to Create Huge Market Potential for TAVR Devices

Up to 53 percent of adult patients with diagnosed severe aortic stenosis are estimated to have bicuspid valve anatomy.

Michael Barbella, Managing Editor 02.18.21

Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production

New plant aims to reach a run rate of 600 million QuickVue tests per year by the end of 2021.

Michael Barbella, Managing Editor 02.18.21

Cardiovascular

Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

Technology approved to treat calcified coronary plaque.

Charles Sternberg, Assistant Editor 02.17.21

Cardiovascular

Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

Informs physicians to cease use of the device until further notice.

Charles Sternberg, Assistant Editor 02.17.21

FDA Appoints its First Cybersecurity Director

University of Michigan associate professor to serve a one-year term within the Center for Devices and Radiological Health.

Michael Barbella, Managing Editor 02.17.21

Rapid Growth Expected for Global Smart Syringe Market

Sector is estimated to swell 11.3 percent annually through 2027.

Michael Barbella, Managing Editor 02.17.21

4 Trends Driving Medical Manufacturing in 2021

Manufacturers across the sector had to manage disruptions last year, but economists say recovery may begin soon.

Emily Newton, Editor-in-Chief, Revolutionized 02.16.21

Qosina and EcoVadis Set to Improve Supply Chain Sustainability for Medical, Pharma and Beauty

Qosina Corp. has partnered with EcoVadis, the world’s most trusted provider of business sustainability ratings

SpectraWAVE Announces $13.2 Million Series A-2 Financing

Funds will accelerate the development of its intracoronary imaging technology and support a regulatory filing.

Michael Barbella, Managing Editor 02.16.21

J. Knipper and Company Adds to its Executive Team

Trio is charged with launching the company's third-party logistics (3PL) unit for 2021.

Michael Barbella, Managing Editor 02.16.21

Diagnostics

BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test

Also shows ability to detect U.K., South African variants of COVID-19.

Sam Brusco, Associate Editor 02.12.21

Fast Setting, Two Component Epoxy Color Coded for Proper Mixing

Master Bond EP51CC is a two component, fast setting epoxy with a color coding system where Part A is white and Part B is black.

The 8 Major Types of PPE Supply Chain Fraud

Medical device manufacturers need to be aware of what’s happening within the space if they are making protection equipment themselves.

Richie M. Hecker, Managing Director, TS Health Supplies Division, Traction & Scale LLC 02.10.21

FDA Clears Rapid Acoustic Pulse Technology for Use in Cellulite

The RAP device induces mechanical disruption in fibrous structures, such as the septae contributing to dimples in cellulite.

Michael Barbella, Managing Editor 02.10.21

Refurbished Medical Imaging Equipment Market to be Worth $21.14 Billion By 2027

The market's growth will be driven primarily by increasing demand for cost-effective medical imaging equipment.

Michael Barbella, Managing Editor 02.10.21

Digital Health

Evolving Trends in the Medical and Orthopedic Devices Industry

There are a number of areas worth keeping an eye on within medtech in 2021 and beyond.

Jacqueline Trovato, Healthcare/Legal Writer 02.09.21

Diagnostics

ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing

System can be used for COVID-19, Influenza A & B, and other viruses.

Charles Sternberg, Assistant Editor 02.09.21

Diagnostics

SmartBreast Corp. Acquires Discover NM750b from GE Healthcare

Will manufacture, market, and distribute the Molecular Breast Imaging scanner.

Charles Sternberg, Assistant Editor 02.09.21

Cardiovascular

Vascular Perfusion Solutions' VP.S Encore Cardiac Transport Device Wins Breakthrough Status

Enables preserving of vascularized tissue for eight hours.

Sam Brusco, Associate Editor 02.09.21

Cardiovascular

Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist

Data show an 86 percent survival rate for cardiomyopathy cardiogenic shock patients.

Michael Barbella, Managing Editor 02.08.21

Diagnostics

Avacta Group and Mologic Enter Commercial Partnership

Aims to accelerate to market Avacta’s SARS-CoV-2 antigen test and support testing in low and middle income countries.

Charles Sternberg, Assistant Editor 02.08.21

Kardium Receives $115 Million in New Financing for Afib Treatment

Money will be used to accelerate commercial growth of the Globe System across Europe.

Michael Barbella, Managing Editor 02.04.21

Contract Manufacturing

Use Vertical Integration to Increase Productivity, Drive Innovation

The concept of vertical integration is simple: a company combining two or more stages of production that would normally be operated by separate companies.

Ryan Lipe, Senior Vice President of Sales & Marketing, MGS 02.03.21

Perspectives on Post-Pandemic: Expect Supply Chain Security to Increase

Dr. Mark Ostwald of Freudenberg Medical speaks to the changes to the supply chain as well as the benefits realized in communication options.

Dr. Mark Ostwald, President—Minimally Invasive Solutions and Europe, Freudenberg Medical 02.03.21

Testing

Element Material Technology Acquires Avomeen

Strengthens its life sciences business unit in North America.

Charles Sternberg, Assistant Editor 02.03.21

Surgical

J&J Granted FDA Approval for Monofocal IOL

TECNIS Eyhance and TECNIS Eyhance Toric II IOLs help treat cataract patients.

Sam Brusco, Associate Editor 02.03.21

A Blueprint for Reducing Medtech Industry's Carbon Footprint

Global warming impact of “single-use” medical devices can be halved by using reprocessed products.

Michael Barbella, Managing Editor 02.03.21

Stericycle Settles Environmental Violations at Its Medical Waste Incinerator

Agreement includes Supplemental Environmental Project to provide low-emitting school buses to local school district.

Michael Barbella, Managing Editor 02.01.21

Patient Monitoring

Hillrom Buys EarlySense's Contact-Free Continuous Monitoring Tech

EarlySense's contact-free continuous monitoring, analytics tech was integrated into the Centrella Smart+ med-surg bed.

Sam Brusco, Associate Editor 02.01.21

Global Ventilators Market to Reach $1.6 Billion by 2030

But the sector is forecast to experience a downturn this year.

Michael Barbella, Managing Editor 02.01.21

Cardiovascular

Medtronic's DiamondTemp Ablation System Gains FDA Approval

Treats patients with recurrent, symptomatic paroxysmal atrial fibrillation unresponsive to drug therapy.

Sam Brusco, Associate Editor 01.29.21

India's NIPT Testing Market Driven by Demand for Non-Invasive Genetic Assessments

Not surprisingly, the market lost value last year due to COVID-19.

Michael Barbella, Managing Editor 01.29.21

Additive Manufacturing Center of Excellence Welcomes New Advisory Board Additions

The new members represent a cross-section of industry, government, research institutions, and non-profit agencies.

Michael Barbella, Managing Editor 01.29.21

Nonin Medical Adds Four New Board Members

Healthcare industry leaders to support the company's next phase of growth.

Michael Barbella, Managing Editor 01.29.21

Diagnostics

Spectrum Solutions Collaborates with UCLA School of Dentistry

Commences study on using saliva in early lung cancer detection and analysis.

Charles Sternberg, Assistant Editor 01.27.21

FDA Clears 3D Acellular Dermal Matrix

The technology is supported by more than 150 peer-reviewed published articles.

Michael Barbella, Managing Editor 01.27.21

Molding

Medtech Makers: Material Science for Micromolding

Patrick Haney of MTD Micro Molding shares his expertise and helps clarify value of understanding the reaction materials experience.

Signia Appoints New President

New executive most recently worked for Essilor of America.

Michael Barbella, Managing Editor 01.25.21

At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities

Public health officials need to stress the importance of mass testing and contact tracing even with several vaccines approved.

Michael Barbella, Managing Editor 01.25.21

Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

Company initiates VFE testing for its porous polymer-based materials; results show components protect against certain aerosolized viruses.

Michael Barbella, Managing Editor 01.22.21

Endoscopic Hemostasis Devices Market Valued at $730 Million

Value has driven by the recent approval of new devices.

Michael Barbella, Managing Editor 01.22.21

Henry Schein Buys Majority Interest in Prism Medical Products

PRISM will operate as a subsidiary of Henry Schein Medical and will be managed separately as an individual division.

Michael Barbella, Managing Editor 01.22.21

TPI Partners with Zeiss

Enables TPI to deliver 3D X-Ray Measurement capabilities for Quality Assurance for its clients.

Charles Sternberg, Assistant Editor 01.21.21

Neurent Medical Closes $25 Million Series B Financing

Supports the expansion of the company’s clinical and commercial operations.

Charles Sternberg, Assistant Editor 01.21.21

Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.

The daily disposable, silicone hydrogel contact lens for astigmatism will roll out concurrently worldwide beginning in February.

Sam Brusco, Associate Editor 01.21.21

Eitan Medical Receives FDA Clearance for Sapphire Infusion System

Upgraded infusion system provides advanced performance and customization capabilities within hospital, pre-hospital and ambulatory environments.

Eitan Medical 01.20.21

Diagnostics

High-Volume COVID Antigen Test Receives FDA EUA

Ortho’s Vitros can run up to 130 tests per hour and helps address testing backlogs, supply shortages, and delayed results.

Ortho Clinical Diagnostics 01.13.21

CMS Expedites Breakthrough Device Access; Industry Applauds

New rule creates an accelerated Medicare coverage pathway for innovative products that the FDA deems ‘breakthrough.’

MPO Staff 01.13.21

Patient Monitoring

Unique Contact Lens Sensor System & Manufacturing Process Developed

New multifunctional lens can provide diversified signals from eyes.

Surrey University 01.12.21

Researchers Receive Funding to Develop Smart Vaccine Device

New smart patch will deliver the COVID-19 vaccine and measure its efficacy through monitoring the body's associated response.

Swansea University 01.12.21

Diagnostics

Olympus and Hitachi Sign Five-Year Contract

Will jointly develop Endoscopic Ultrasound Systems.

Olympus Corporation 01.11.21

MGS Acquires Formteknik

Expands the MGS team to 1,500 employees, with 11 facilities globally.

MGS 01.08.21

Diagnostics

CareDx Partners with IDbyDNA

Will develop AlloID, a transplant patient-specific metagenomic infectious disease test platform.

Globe Newswire 01.08.21

Sera Prognostics Partners with Anthem and HealthCore

Aims to improve outcomes for preterm babies.

Globe Newswire 01.08.21

Solvay Partners With PrinterPrezz on 3D Printing for Medical Devices

Companies are collaborating on 3D printing selective laser sintering (SLS) solutions for implants and other medical devices.

Solvay 01.08.21

Diagnostics

Quantitative Transmission Ultrasound Outperforms Mammography

QT Imaging completes first-in-human study of transmission ultrasound as a new imaging technology for breast health screening.

PRNewswire 01.07.21

Neurological

BioSerenity Achieves FDA Clearance for Wearable Device System

Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.

PRNewswire 01.07.21

Vesper Medical Announces First Enrollment in the VIVID Trial

Company initiates pivotal clinical study for next-generation deep venous stent.

Vesper Medical 01.06.21

Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe

Gold-tipped force sensing ablation catheter earns CE Mark.

Globe Newswire 01.06.21

Chronic Disease | Diagnostics

Hologic to Buy Cancer Test Maker Biotheranostics for $230M

Accelerates Hologic’s entry into the oncology growth market, provides new lab capabilities.

Business Wire 01.06.21

Thyroid Function Tests Market in India to Reach $125 Million in 2025

Thyroid stimulation hormone tests are expected to account for more than 75 percent of the market.

GlobalData 01.06.21

Diagnostics

EKF Introduces Accurate Quantitative COVID-19 Antibody Test Kit

The test kit is one of first to detect both the presence and precise levels of COVID-19 neutralizing antibodies.

EKF Diagnostics 01.05.21

3D/Additive Manufacturing

Researchers Develop New Combined Process for 3D Printing

Enables active medical agents to be incorporated into pharmaceutical products or luminous liquids to be integrated into materials.

Martin-Luther-Universität Halle-Wittenberg 12.18.20

FOREFRONT MEDICAL TECHNOLOGY ANNOUNCES UNIQUELY-DESIGNED COVID-19 TEST SWAB

...

New Global Headquarters for Freudenberg Medical

The 37,000 sq. ft. Beverly, Mass. location is equipped with ISO Class 8 cleanrooms for medical molding and assembly.

CM&B Inc. 12.17.20

Impact of COVID-19 on the Medtech Supply Chain

Agility, reliability, and resiliency all describe objectives of a company’s supply chain management system.

Joe McBeth, Vice President, Global Supply Chain, Jabil 12.16.20

PTC to Acquire SaaS PLM Leader Arena Solutions

PTC reaffirms its cash flow targets for fiscal year 2021.

PR Newswire 12.16.20

Mike on Medtech: Communicating with the FDA

Mike Drues and Sean Fenske discuss methods of communicating with the agency and share best practices for doing so.

Sean Fenske, Editor-in-Chief 12.15.20

Cardiovascular

Innovative Health Obtains Patent for Microlumen Reprocessing Technology

Paves the way for future innovation in the field by the company.

Innovative Health Inc. 12.11.20

Cardiovascular

Abbott Launches OCT Virtual Reality Training for Cardiologists

VR training improved cath lab staff learning engagement by 45 percent, knowledge retention by 72 percent.

Abbott Laboratories 12.09.20

Diversified Plastics Appoints Engineering Manager

New executive has nearly 30 years of experience serving in leadership positions in a range of industries.

Diversified Plastics Inc. 12.09.20

BellaSeno Establishes High-Throughput Additive Manufacturing Facility for Resorbable Implants

Manufacturing at the facility will be based on the no-touch approach to significantly improve the safety and sterility of medical implants.

BellaSeno GmbH 12.09.20

Sofwave Medical Granted CE Mark for Skin Tightening, Wrinkle Reduction Device

Company's device also received regulatory approval from the Medical Device Division of the Israeli Ministry of Health.

PR Newswire 12.09.20

Chronic Disease

Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine

The Carpediem system is designed to treat patients requiring renal replacement therapy weighing between 2.5 and 10 kilograms (5.5 to 22 pounds).

PR Newswire 12.08.20

Materials

DURECT to Sell LACTEL Absorbable Polymer to Evonik for $15M

Expands Evonik's position as a global CDMO for drug delivery solutions.

PR Newswire 12.08.20

Survey Finds On-Site Inspections Plummeted by 93 Percent

Findings from Greenlight Guru survey reveal internal divides within organizations are making medical device companies less competitive.

Greenlight Guru 12.08.20

Patient Monitoring

Medtech Matters: Talking Medtech with Joe Mullings

MPO's Sean Fenske speaks with Joe Mullings, medtech recruiter and host of TrueFuture, about what’s got him excited in the medtech space.

Sean Fenske, Editor-in-Chief 12.08.20

Molding

A 'Trial and Error' Approach to Micromolded Parts

The medical industry's stringent requirements makes innovation difficult for injection-molded components.

Michael Barbella, Managing Editor 12.07.20

Diagnostics

CRISPR-Based COVID-19 Test Uses Smartphone Camera

The rapid, one-step mobile test could help combat the pandemic and fully reopen communities.

PR Newswire 12.07.20

Digital Health

Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

Industry experts share their advice on factors medical device manufacturers need to consider for the coming year to stay ahead.

Nick Tippmann, Vice President Of Marketing, Greenlight Guru 12.04.20

Molding

Tooling Precision is Key to Micromolding Success

Tool quality dictates part quality for all sizes of medical components.

Michael Barbella, Managing Editor 12.03.20

Motion Dynamics Acquires ViaMed Holdings

Enables Motion Dynamics to provide a broader range of capabilities, products, and services.

Motion Dynamics LLC 12.03.20

3D Systems, Veterans Health Administration Collaborate to Improve Patient Care

Additive manufacturing solutions at the point of care aim to foster innovation and enhance patient care.

3D Systems 12.03.20

Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon

No difference in mortality between patients treated with Philips' Stellarex drug-coated balloon and those treated with percutaneous angioplasty.

Royal Philips 12.03.20

Cardiovascular

LivaNova to Sell Heart Valve Biz to Gyrus Capital for $73M

Enables company to sharpen its focus within primary platforms, neuromodulation and cardiovascular.

Business Wire 12.03.20

TRIMEDX Acquires Centurion Service Group

Expands TRIMEDX’s comprehensive clinical asset management solution.

TRIMEDX 12.02.20

Wytech Industries Names Henry Burmeister as CFO

Complex specialty core wire manufacturer adds to its management team.

Wytech Industries 12.02.20

Foxx Life Sciences Appoints SVP of Global Sales and Business Development

Mark Robillard brings industry knowledge and experience in all facets of the life science tools industry.

Foxx Life Sciences 12.01.20

RSNA News: Royal Philips Introduces Patient Management System

Offers personalized care to patients during the COVID-19 pandemic.

Royal Philips 11.30.20

Diagnostics

RSNA News: Siemens Introduces Cios Flow Mobile C-arm System

Easy-to-use system helps make surgical interventions more efficient and patient-friendly.

Siemens Healthineers 11.30.20

Molding

Smaller Cavity Features Not Always Sensible for Micromolded Products

Though the need to reduce size is crucial, small cavity characteristics may be challenging to reproduce in volume.

Michael Barbella, Managing Editor 11.24.20

Tubing & Extrusion

On Line Controls Celebrates 40 Years

The firm manufactures MicroAir technologies for tubing extrusion.

On Line Controls Inc. 11.24.20

R&D & Design

New Project-Based Rapid Precision Prototyping Program

Your First Step Is the Most Important

Chronic Disease

Increasing Comfort for Chemotherapy Patients

Leveraging a freelance researcher in bringing the Chemo Mouthpiece to market—A case study.

Ramya Sriram, Digital Content Manager, Kolabtree 11.24.20

Cardiovascular

Draper Develops Noncontact ECG Sensor

Enables direct measurement of the heart’s three-dimensional (3D) bioelectric field.

Draper 11.24.20

Highly Flexible UV Curable Adhesive Meets ISO 10993-5 Standard for Cytotoxicity

Product: UV15X-6Med-2LV

Reducing Exposure During Customer Audits

Two audit streamlining methods are highlighted to help suppliers reduce exposure from outside visitors associated with customer audits.

Nicolle Cannon, Founder/CEO, Cannon Quality Group 11.23.20

Cardiovascular

VitalConnect Lanches VitalPatch RTM Cardiac Monitoring Solution

Monitors for 21 cardiac arrhythmias through a unique AI-based ECG analysis solution and captures data on four key vital signs.

Business Wire 11.23.20

Chronic Disease | Patient Monitoring

FDA OKs Baxter's Homechoice Claria with Sharesource

Sharesource is a two-way remote patient management platform for patients on peritoneal dialysis.

Business Wire 11.23.20

First Patient Enrolled in NovaSignal's Intelligent Ultrasound Clinical Trial

The FDA-cleared NovaGuide is designed to autonomously locate major blood vessels and assess blood flow.

Globe Newswire 11.23.20

Patient Monitoring

Chronic Disease

Varian Begins First Human Trial of FLASH Therapy for Cancer

ProBeam particle accelerator was modified to enable radiation therapy delivery at ultra-high dose rates.

PR Newswire 11.20.20

Diagnostics

GE Healthcare Pioneers Photon Counting CT with Prismatic Sensors Buy

Gains Deep Silicon detector technology for photon counting computed tomography (PCCT).

Business Wire 11.20.20

New Study Validates the Efficacy of Ethicon’s LINXReflux Management System

LINX eliminated daily dependance on acid-reflux medications in 79% of GERD patients.

Ethicon 11.20.20

Molding

Miniaturization of Medical Devices Creating Big Assembly Challenges

Extremely tight tolerances leave no room for error.

Michael Barbella, Managing Editor 11.20.20

FOLLOW:

YOU SEARCHED BY...

SEARCH BY...

Outsourcing Directory

Country

Outsourcing Directory

Swiss Automation Inc.

Company Headquarters

Outsourcing Directory

In-Vitro Diagnostic Categories

Medical Device Categories

Related Content